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NCT05770687 Clinical Trial

SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients With Acute Myocardial Infarction, a Prospective, Multi-center Registry Study

Diabetes Mellitus, Type 2 Clinical Trial

— RECORD-AMI  

Official title:
Real World Observation of SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients With Acute Myocardial Infarction, a Prospective, Multi-center Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05770687
Other study ID # KC19OEDI0591
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date December 31, 2026

Study information
Verified date March 2023
Source Seoul St. Mary's Hospital
Contact Kiyuk Chang, MD, PhD
Phone 82-2-2258-1139
Email kiyuk@catholic.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective trials performed on type 2 diabetes patients without established cardiovascular disease has shown that SGLT2 inhibitors reduce cardiovascular risk. No studies have yet examined the occurrence of cardiovascular disease in patients with acute myocardial infarction. The investigators designed the current study to evaluate the most ideal oral hypoglycemic agent in type 2 diabetes patients undergoing percutaneous coronary intervention for acute myocardial infarction. The investigators hypothesize that the use of SGLT-2 inhibitors will reduce cardiovascular events and modify left ventricular remodeling after myocardial infarctions.

Description:

8 hospitals of the Catholic University of Korea with high-volume percutaneous coronary intervention of following hospitals are participating in the current study. Seoul St. Mary's Hospital, Seoul, South Korea Yeoido St. Mary's Hospital, Seoul, South Korea Uijongbu St. Mary's Hospital, Gyeonggi-do, South Korea Eunpyeong St. Mary's Hospital, Seoul, South Korea Bucheon St. Mary's Hospital, Gyeonggi-do, South Korea Incheon St. Mary's Hospital, Incheon, South Korea St. Vincent Hospital, Gyeonggi-do, South Korea Daejeon St. Mary's Hospital, Daejeon, South Korea After recruitment of all patients, the control group will be selected from a previous prospective cohort (COREA-AMI, NCT02385682) using identical inclusion / exclusion criteria except for use of SGLT2 inhibitors. The control cohort of 3,000 patients will be selected using 1:3 propensity matching.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Acute myocardial infarction who were treated with percutaneous coronary intervention - Type 2 diabetes mellitus - Started SGLT2 inhibitors <1 month before/after PCI Exclusion Criteria: - Type 1 diabetes mellitus - Insulin / GLP-1 analogue users - Previous users of SGLT2 inhibitors - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SGLT2 inhibitor
Patients started on SGLT2 inhibitors after PCI for AMI

Locations
Country Name City State
Korea, Republic of Seoul St. Mary's Hospital Seoul

Sponsors (18)
Lead Sponsor Collaborator
Kiyuk Chang Andong Hospital, Bucheon St. Mary's Hospital, Chungnam National University Hospital, Daejeon St. Mary's hospital, Incheon St.Mary's Hospital, Inje University, Jeju National University Hospital, Korea University Anam Hospital, Kyungpook National University Hospital, Pusan National University Hospital, Pusan National University Yangsan Hospital, Sejong General Hospital, Seoul St. Mary's Hospital, St Vincent's Hospital, St. Carollo General Hospital, Uijeongbu St. Mary Hospital, Yeouido St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cardiac and cerebrovascular events A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization 2 years
Secondary Cardiac death Cardiovascular death 2 years
Secondary Nonfatal myocardial infarction non-fatal myocardial infarction 2 years
Secondary Nonfatal stroke non-fatal stroke 2 years
Secondary Hospitalization for heart failure hospitalization for HF 2 years
Secondary Target lesion revascularization Revascularization performed for target lesion 2 years
Secondary Target vessel revascularization Revascularization performed for target vessel 2 years
Secondary Non-target vessel revascularization Revascularization performed for non-target vessel 2 years
Secondary Definite/Probable stent thrombosis Definite or probable stent thrombosis 2 years
Secondary Absolute and percentage change of microalbuminuria Absolute and percentage change of microalbuminuria 2 years
Secondary Absolute and percentage change of HbA1c Absolute and percentage change of HbA1c 2 years
Secondary Absolute and percentage change of NT-proBNP Absolute and percentage change of NT-proBNP 2 years
Secondary Absolute and percentage change of BMI Absolute and percentage change of BMI 2 years
Secondary Absolute and percentage change of body weight Absolute and percentage change of body weight 2 years
Secondary Changes in echocardiograhic parameters LVEF, LVEDV, LVESV, LVMI, E, A, DT, E/E' 1 year
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